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No annual shareholder meeting date has been released for 2022, what's up with that ?
Who is Christine Redmond MPH ?... And why was there no press release of her hire as a VP in January 2022
You could see a nice move in Brainstorm ( BCLI ), in 2022
20 million dollars of share sales, not 20 million shares of dilution
Might want to investigate Brainstorm ( BCLI )
Here is the Brainstorm reverse split info
NEW YORK, NY and PETACH TIKVAH, ISRAEL / ACCESSWIRE / September 16, 2014 / BrainStorm Cell Therapeutics (OTCQB: BCLI) (OTCQB: BCLID), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that at 11:59 p.m. on September 15, 2014, (the "Effective Date"), it effected a one (1) for fifteen (15) reverse split of its issued and outstanding common stock (the "Reverse Split") as a step toward the Company's intention to have its common stock listed on the NASDAQ Capital Market.
"We view the Reverse Split as an important step in BrainStorm's corporate development. The maintenance of a minimum closing price of $3.00 for at least five (5) trading days would fulfill the share price requirement for an uplisting to NASDAQ," said Tony Fiorino, Chief Executive Officer of BrainStorm. He continued, "Our investors strongly supported this initiative at our August 14, 2014 Annual Stockholder Meeting, and I am pleased that we have moved quickly towards this goal."
Humanigen should be just fine post reverse split and NASDAQ listing. Brainstorm (BCLI) did a reverse split and uplisting onto the NASDAQ a few years ago, and the stock price has continue to gain positive momentum. And since HGEN is much further along in its development, the stock price will reward patient investors
Got lucky, 150 shares added
https://www.cnbc.com/video/2020/04/03/past-outbreaks-history-pandemics-coronavirus-covid-19-squawk-box.html
Richard Preston is out with a new book called “Crisis in the Red Zone: The Story of the Deadliest Ebola Outbreak in History, and of the Outbreaks to Come.” He joins “Squawk Box” to discuss the coronavirus outbreak as the U.S. tries to figure out where we are in the curve.
This was about as informative an interview on the subject of Covid19
he mentions the Bioreactor method for creating antibodies
In 2014 Brainstorm and Octane successfully constructed a Bioreactor
NEW YORK, NY and PETACH TIKVAH, ISRAEL and KINGSTON, ON--(Marketwired - June 27, 2014) - BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, and Octane Biotech Inc., a Canadian firm that focuses on clinical systems for cell and tissue therapy, announced today that they have reached an important milestone in their technology collaboration, successfully constructing an Alpha prototype of a customized bioreactor for BrainStorm's NurOwn™ neurotrophic-factor secreting mesenchymal stem cells. The proprietary bioreactor under development will provide BrainStorm with large-scale manufacturing capabilities, enabling it to achieve economies of scale for its autologous stem cell product.
Octane and BrainStorm have successfully developed a sophisticated Alpha prototype of the NurOwn™ Bioreactor, utilizing a customized disposable cartridge that is dedicated to the intricacies of BrainStorm's NurOwn™ process. Operating within the Cocoon™ clinical delivery platform pioneered by Octane, the Alpha prototype automates the entire NurOwn™ process for unmatched process control and production economy. Based on this first working prototype, BrainStorm and Octane are quickly advancing to the next stage of system qualifications in anticipation of adopting all the benefits of cell production automation as quickly as possible for full clinical use
Intratracheal administration of exosomes extracted from MSC’s using NurOwn® technology resulted in statistically significant improvement in multiple lung parameters in a mouse mode
More than 500 clinical trials are under way world-wide in the race to find an effective treatment for Covid-19. Everybody wants it; nobody has it—yet. But one of the most promising therapies for Covid-19 patients uses “medicinal signaling cells,” or MSCs, which are found on blood vessels throughout the body.
In preliminary studies, these cells cut the death rate significantly, particularly in the sickest patients. With a powerful 1-2-3 punch, these cells eliminate the virus, calm the immune overreaction known as a cytokine storm, and repair damaged lung tissue—a combination offered by no other drug. This type of regenerative medicine could be as revolutionary as Jonas Salk’s polio vaccine.
BCLI trading 17
CYDY and HGEN, worth a look
BCLI, told you boys a while ago to play this one
Keep an eye on Brainstorm ( BCLI )
Stay with Brainstorm ( BCLI )
Edgardo Ferr
@fierro7676
·
$BCLI "The Hospital has applied to the MoH for an extension of the approval and also to expand the HE regulatory pathway to include an additional 13" ALS patients in Israel will be all over to get this approved IMO
Stay with Brainstorm ( BCLI )
Don't Sleep on Brainstorm, BCLI
Brainstorm ( BCLI ) market may provide another solid buying opportunity
Chen Schor
Co-Founder, President and Chief Executive Officer of resTORbio
Chen Schor has served as a member of BrainStorm’s board of directors since 2011, and was appointed as a member of the Audit Committee in November 2017.
Just a heads up, there is a connection between TORC and Brainstorm ( BCLI )
Keep an eye on Brainstorm BCLI
Small share float, company very conservative with cash, since NurOwn appears to be working to slow the progression of ALS, it should work for MS patients as well, company could be a monster
Keep an Eye on Brainstorm ( BCLI )
BrainStorm Cell Therapeutics and FDA Agree to Potential NurOwn® Regulatory Pathway for Approval in ALS
NEW YORK, Feb. 11, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc., (BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Company recently held a high level meeting with the U.S. Food and Drug Administration (FDA) to discuss potential NurOwn® regulatory pathways for approval in ALS. Repeated intrathecal administration of NurOwn (autologous MSC-NTF cells) is currently being evaluated in a fully enrolled Phase 3 pivotal trial in ALS (NCT03280056).
In the planned meeting with senior Center for Biologics Evaluation and Research (CBER) leadership and several leading U.S. ALS experts, the FDA confirmed that the fully enrolled Phase 3 ALS trial is collecting relevant data critical to the assessment of NurOwn efficacy. The FDA indicated that they will look at the "totality of the evidence" in the expected Phase 3 clinical trial data. Furthermore, based on their detailed data assessment, they are committed to work collaboratively with BrainStorm to identify a regulatory pathway forward, including opportunities to expedite statistical review of data from the Phase 3 trial.
Both the FDA and BrainStorm acknowledged the urgent unmet need and the shared goal of moving much needed therapies for ALS forward as quickly as possible
https://finance.yahoo.com/news/brainstorm-cell-therapeutics-fda-agree-110010642.html
Autologous stem cells sound a cord
“Enrichment is the hottest trend in neurodegenerative disease space,” asserts Ralph Kern, MD, chief operating officer and chief medical officer, Brainstorm Cell Therapeutics. “The oncology field was drastically transformed by utilizing genetic insights. In the neurosciences, we can generate a world of analytics from just a few drops of cerebrospinal fluid.”
Success in ALS clinical trials has remained elusive, with only a couple of new treatments approved in the past decade. Kern is certain that this phenomenon is largely due to the considerable heterogeneity in ALS symptoms. To overcome this problem, Brainstorm invests in biomarkers of cerebrospinal fluid to gain insights into disease mechanisms and to optimize patient stratification.
The company’s lead product for ALS, NurOwn®, contains injectable autologous mesenchymal stem cells (MSCs) that have been differentiated in vitro and stimulated to produce neurotrophic factors (NTFs). NTFs are known to promote the survival, repair, and regeneration of neurons. NurOwn® is injected directly into the spinal fluid, bringing it in immediate contact with affected motor neurons in the spinal cord. Changes in NTFs, inflammatory biomarkers, and biomarkers of neurodegenerative damage can be assessed directly from the same port.
The Phase II data demonstrated reduction in rate of ALS disease progression in the NurOwn treatment group. Cerebrospinal fluid biomarkers confirmed the secretion of NTFs and a reduction in inflammatory activity in the patients treated with NurOwn. The treatment effect was statistically significant in a subpopulation of participants with more rapid disease progression.
Kern predicts that the regulatory agencies will have to change the way they shape the drug development process, shifting from a preoccupation with common efficacy signals and large heterogeneous populations, to a willingness to favor unique efficacy signals and small homogeneous populations. “Signal readout is most easily observed in rapid progressors,” notes Kern. “[That is where] we can see meaningful slowing of the disease.”
He envisions that biological “software” solutions will become more prevalent, solutions that attempt to reprogram the disease environment by using the body’s own cells and repeatedly delivering new information. During Brainstorm’s manufacturing process, autologous MSCs are cryopreserved, with multiple doses of treatment being prepared from one bone marrow aspirate. This approach can generate multiple treatment doses while reducing the need for additional aspirates.
Full article link
https://www.genengnews.com/insights/neurodegenerative-treatments-build-to-a-tipping-point/
Autologous stem cells sound a cord
“Enrichment is the hottest trend in neurodegenerative disease space,” asserts Ralph Kern, MD, chief operating officer and chief medical officer, Brainstorm Cell Therapeutics. “The oncology field was drastically transformed by utilizing genetic insights. In the neurosciences, we can generate a world of analytics from just a few drops of cerebrospinal fluid.”
Success in ALS clinical trials has remained elusive, with only a couple of new treatments approved in the past decade. Kern is certain that this phenomenon is largely due to the considerable heterogeneity in ALS symptoms. To overcome this problem, Brainstorm invests in biomarkers of cerebrospinal fluid to gain insights into disease mechanisms and to optimize patient stratification.
The company’s lead product for ALS, NurOwn®, contains injectable autologous mesenchymal stem cells (MSCs) that have been differentiated in vitro and stimulated to produce neurotrophic factors (NTFs). NTFs are known to promote the survival, repair, and regeneration of neurons. NurOwn® is injected directly into the spinal fluid, bringing it in immediate contact with affected motor neurons in the spinal cord. Changes in NTFs, inflammatory biomarkers, and biomarkers of neurodegenerative damage can be assessed directly from the same port.
The Phase II data demonstrated reduction in rate of ALS disease progression in the NurOwn treatment group. Cerebrospinal fluid biomarkers confirmed the secretion of NTFs and a reduction in inflammatory activity in the patients treated with NurOwn. The treatment effect was statistically significant in a subpopulation of participants with more rapid disease progression.
Kern predicts that the regulatory agencies will have to change the way they shape the drug development process, shifting from a preoccupation with common efficacy signals and large heterogeneous populations, to a willingness to favor unique efficacy signals and small homogeneous populations. “Signal readout is most easily observed in rapid progressors,” notes Kern. “[That is where] we can see meaningful slowing of the disease.”
He envisions that biological “software” solutions will become more prevalent, solutions that attempt to reprogram the disease environment by using the body’s own cells and repeatedly delivering new information. During Brainstorm’s manufacturing process, autologous MSCs are cryopreserved, with multiple doses of treatment being prepared from one bone marrow aspirate. This approach can generate multiple treatment doses while reducing the need for additional aspirates.
Full article link
https://www.genengnews.com/insights/neurodegenerative-treatments-build-to-a-tipping-point/
Brainstorm ( BCLI ) half a million shares traded today ....
Just a Heads Up, Clem Schor sits on the Board of Directors of Brainstorm
If you wait to December for the results, you may have to may 5x more for BCLI shares, plenty of research intangibles not properly priced by the market.
https://soundcloud.com/rarecast/programming-cells-to-produce-neuroprotective-factors-to-treat-als
ALS is a progressive neurodegenerative disease. As motor neurons die, people with the condition grow weaker and lose motor function. For most, death occurs within three to five years of diagnosis. Brainstorm Cell Therapeutics is conducting a phase 3 clinical trial of its autologous stem cell therapy that programs cells taken from patients to produce neuro-protective factors that promote the survival of neurons. We spoke to Ralph Kern, chief operating officer and chief medical officer of Brainstorm Cell Therapeutics, about ALS, the company’s late-stage experimental therapy, and how its approach may provide benefits for patients with other neurodegenerative disease
https://soundcloud.com/rarecast/programming-cells-to-produce-neuroprotective-factors-to-treat-als
ALS is a progressive neurodegenerative disease. As motor neurons die, people with the condition grow weaker and lose motor function. For most, death occurs within three to five years of diagnosis. Brainstorm Cell Therapeutics is conducting a phase 3 clinical trial of its autologous stem cell therapy that programs cells taken from patients to produce neuro-protective factors that promote the survival of neurons. We spoke to Ralph Kern, chief operating officer and chief medical officer of Brainstorm Cell Therapeutics, about ALS, the company’s late-stage experimental therapy, and how its approach may provide benefits for patients with other neurodegenerative disease.
ALS Stem Cell Treatment In Phase 3 Study
Simple cost effective. Simpler and safer than car-t
20 minute outpatient bone marrow aspiration enough for 3 years.
12 days to produce intermediate product.
7 days to produce injectable and ship.
Go home same day following injection.
No gene insertion.
No vector.
Almost off the shelf product.
Closed circuit bioreactors to reduce clean rooms and costs 30 to 40%.
“We will not be in headlines of high prices”.
Those that are smart, will buy a few shares of Brainstorm ( BCLI )
A little insider buying @ Brainstorm ( BCLI )
https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001137883&type=&dateb=&owner=include&count=40
Health Ministry agrees to let Tel Aviv hospital charge five foreigners $300,000 each for treatment that is still undergoing efficacy testing, while eight Israels will get it for free The Health Ministry has agreed to let the Sourasky Medical Center in Tel Aviv charge foreign patients for treatment with an experimental drug not approved for use yet anywhere in the world, to treat arterial lateral sclerosis. The payment for use of the experimental therapy is supposed to fund the treatment of Israeli patients and also, treatment with the drug will not be part of the clinical trials it is undergoing.
https://www.haaretz.com/israel-news/.premium-foreign-patients-to-subsidize-experimental-treatment-for-israelis-with-als-1.6956407
Below is the another opinion of what is happening @ Brainstorm. The company is meeting again with the FDA in September, plus the company has 5 paying patients in Israel that is not recorded on the q2 report
Matt yesterday
@Peter Yes, I agree. My interpretation of the conference call is that the company is pursuing two paths at the same time. First, it will complete its phase 3 trial. That trial will be fully enrolled by the end of Sept to the beginning of Oct. Results will be available about a year later. Second, it is working out a non-binding pathway for approval with the FDA. Once the trial is fully enrolled, the company could begin providing paid treatments in the US. They wouldn't be as numerous as with full FDA approval. But the FDA recognizes that it must approve more effective treatments than Radicava and Rilutek.
Brainstorm BCLI, keep an eye on this one
https://iamals.org/news/press-release-groundbreaking-meeting-with-fda/
I AM ALS becomes the first ALS patient advocacy group to bring together senior FDA leadership and a biotechnology company for an in-person meeting
WASHINGTON, D.C. – In a first-of-its-kind meeting, I AM ALS brought together senior leadership from the Food and Drug Administration (FDA) and Brainstorm Cell Therapeutics, a U.S. biotechnology company that is developing a potential breakthrough ALS treatment, NurOwn. NurOwn has been studied in 4 clinical trials to date, and is currently the only ALS treatment nearing the end of its phase 3 clinical trial.
The groundbreaking meeting was the first in-person meeting ever convened by an ALS patient advocacy group between senior FDA leadership and a biotechnology company. I AM ALS arranged the meeting to discuss Brainstorm’s ongoing phase 3 clinical trial of NurOwn as well as efforts to speed treatment access to the ALS patient community.
The meeting enabled an open dialogue between the FDA and Brainstorm that sets the stage for future meetings to explore bringing this treatment to those living with ALS as expeditiously as possible.
I AM ALS presented the FDA with two petitions signed by more than 20,000 individuals calling on the FDA to release its updated Clinical Trial Guidance for ALS Treatments and to approve pending ALS treatments as expeditiously as possible.
AGING Is targeting brain inflammation the key to beating Alzheimer's disease?
The past decade of Alzheimer's disease research has been fraught with disappointment.
Years of focus on one hallmark of the disease ultimately resulted in no progress toward treatment or prevention.
But next week, when top scientists gather in Los Angeles at the Alzheimer’s Association International Conference, an annual meeting, many will present research on a different target: inflammation.
"The big breakthrough is that neuroinflammation is the target. It's killing the bulk of the nerve cells that leads to dementia," said Rudolph Tanzi, a professor of neurology at Harvard University and the director of neurology at Massachusetts General Hospital.
https://www.nbcnews.com/health/aging/targeting-brain-inflammation-key-beating-alzheimer-s-disease-n1014121
“NurOwn® has the potential to stabilize or improve function by reducing brain inflammation, protecting the brain against ongoing damage, and activating brain repair through the delivery of repair molecules, also known as NTFs,” Kern told NeurologyLive. “This unique approach has the potential to address an important unmet need in progressive MS, for which there are few treatment options.”